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FDA 510(k)

Welspun Health Surgical Mask

K-Number: K211536 · 2021-09-01

ApplicantWelspun India Limited
Decision Date2021-09-01
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Welspun Health Surgical Mask is a medical device manufactured by Welspun India Limited. It received FDA 510(k) clearance on 2021-09-01 under approval number K211536. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Welspun Health Surgical Mask?

Welspun Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-09-01. It is manufactured by Welspun India Limited. The 510(k) number is K211536.

When was Welspun Health Surgical Mask approved by the FDA?

Welspun Health Surgical Mask received FDA 510(k) clearance on 2021-09-01, under approval number K211536.

What company makes Welspun Health Surgical Mask?

Welspun Health Surgical Mask is manufactured by Welspun India Limited.

What is the FDA product code for Welspun Health Surgical Mask?

The FDA product code for Welspun Health Surgical Mask is FXX.

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Related PubMed Literature

PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Related Devices (Code: FXX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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